Clinical OMICs - Volume 3, Issue 9 - 29

www.clinicalomics.com PeopleImages.com / Getty Images pen), so can other human or environmental factors. Assuming that good lab science begets good quality is an erroneous-and dangerous- assumption. Just ask the FDA. In late 2015, the Agency released a report titled "The public health evidence for FDA Oversight of Laboratory Developed Tests: 20 case studies." In a nutshell, the lengthy report offers specific examples of LDTs gone south, such as cases of LDTs that lacked evidence of clinical validity or contained unsupported manufacturers' claims, as well as cases where tests were marketed and used without having undergone premarket performance also maintain that CLIA does adereviews. It is highly unlikely that quately address LDT safety concerns, few, if any, of the cases, which span device quality, and risk in its Individa wide variety of immunoassay and ualized Quality Control Plan (IQCP). molecular methods, would have surIntroduced in 2014, an IQCP allows vived the FDA's rigorous premarket a lab to customize its quality control review process. Moreover, all listed (QC) practices to suit its unique testcases occurred in ing environment CLIA-compliant and patients. IQCP labs. applies to all non"Can I get a Ph.D. in lab science CLIA-phites waived testing, argue that the FDA to digest and implement quality including existing management principles?" "cherry-picked" a and new test syshandful of assays tems, and all CLIA "Yes, but only after a frontal and ignored the specialties and sublobotomy!" thousands that specialties, excludare successfully ing pathology. offered to patients on a regular basis. However, in this writer's opinion, while (You can download the clinical labs' IQCP is a step in the right direction, it rebuttal to the FDA report, which is is still not enough to ensure the safety articulated in a report released by and efficacy of high-risk LDTs. Often, the Maryland-based Association for an IQCP is little more than a band-aid Molecular Pathology here.) Those or stop-gap implemented in the lab opposed to expanded FDA oversight in an attempt to build in quality after the fact, e.g., after the poor design of a test. The ramifications are increased errors. The Origin of Risk and the Danger of Groupthink So, where does the origin or birth of risk and error happen? In the very design of the processes, methods and outcomes that make up the products, tests, activities and any other aspect of the attributes of an idea or concept to be executed. Why? Because one of the riskiest factors in providing what seems to be a sound outcome of groupthink is unintentionally introducing a myriad of human factors that put the outcome at risk. Groupthink by its very nature introduces failure because it does not use process. I am speaking of the regimen of due process and, in this case, the quality of thinking about thinking. (continued on next page) September 2016 Clinical OMICs 29 http://www.PeopleImages.com http://www.clinicalomics.com

Table of Contents for the Digital Edition of Clinical OMICs - Volume 3, Issue 9